Pharmacovigilance Japanese Drug Safety Hiring at Syneos Health
Company: Syneos Health
Position: Safety & Pharmacovigilance (PV) Specialist I – Japanese
Location: Pune, India
Experience Required: 1 to 4 Years
Salary Range: ₹6 – ₹15 LPA
Educational Qualifications: B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Life Sciences
Syneos Health, a global leader in fully integrated biopharmaceutical solutions, is currently inviting applications for the position of Safety and Pharmacovigilance (PV) Specialist I with Japanese language proficiency. This is an excellent opportunity for professionals with a background in drug safety, clinical research, or pharmacovigilance, who are fluent in Japanese and looking to advance their career with a globally renowned organization. Pharmacovigilance Japanese Drug Safety
If you are passionate about ensuring patient safety, have strong attention to detail, and want to be part of a mission-driven team that contributes to the successful development of life-saving therapies, this could be the perfect role for you.
About the Role
The Safety & PV Specialist I will support global drug safety activities, with a special focus on processing Japanese language case reports and ensuring compliance with international pharmacovigilance guidelines. This role requires close collaboration with medical experts, regulatory teams, and pharmacovigilance databases. Pharmacovigilance Japanese Drug Safety
You will play a key role in processing and evaluating individual case safety reports (ICSRs), handling adverse event data, and supporting compliance with ICH-GCP, GVP, and regulatory authority requirements. Pharmacovigilance Japanese Drug Safety
Key Responsibilities
- Enter and manage individual case safety reports (ICSRs) into global safety databases in accordance with established timelines and SOPs
- Triage, review, and process ICSRs for completeness, consistency, and regulatory compliance
- Perform MedDRA coding for reported adverse events, medical history, and concomitant medications
- Draft narrative summaries and prepare expedited reports for submission to health authorities
- Participate in literature surveillance for drug safety information and adverse event detection
- Validate and submit xEVMPD product records using the correct MedDRA terminology
- Identify and resolve duplicate ICSRs, ensuring accuracy in data records
- Support SPOR/IDMP activities and assist in managing safety dictionaries
- Maintain Trial Master File (TMF) documentation and prepare for audits and inspections
- Collaborate with cross-functional teams to support drug development and post-marketing safety
Required Qualifications and Skills
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or a related field
- 1 to 4 years of experience in pharmacovigilance, drug safety, or clinical research
- Proficiency in reading and writing Japanese is mandatory
- Familiarity with global safety databases such as Argus, ARISg, or Veeva Safety
- Strong understanding of ICH-GCP, Good Pharmacovigilance Practices (GVP), and global regulatory requirements
- Excellent attention to detail and organizational skills
- Effective written and verbal communication skills
- Ability to manage multiple priorities and deliver accurate results under tight deadlines
About Syneos Health
Syneos Health is a fully integrated biopharmaceutical solutions organization that works across clinical development, medical affairs, and commercial functions. With over 29,000 employees across more than 110 countries, Syneos Health partners with companies to accelerate the delivery of innovative therapies to market and improve patient outcomes. Pharmacovigilance Japanese Drug Safety
The organization is known for driving innovation in clinical trials, medical affairs, and commercialization through real-world experience and data-driven insights. Syneos Health has supported 94 percent of FDA-approved drugs and 95 percent of EMA-authorized products in recent years.
Why Join Syneos Health? Pharmacovigilance Japanese Drug Safety
1. Career Growth and Development
Syneos Health offers structured training programs and continuous learning opportunities to help employees grow professionally and stay updated with global industry standards.
2. Global Collaboration
Work alongside highly skilled professionals and diverse teams across the globe. The collaborative work environment ensures high performance and learning across borders.
3. Purpose-Driven Work
Employees at Syneos Health are involved in meaningful projects that improve global health outcomes. Your role will directly contribute to the safety and efficacy of new and existing medicines.
4. Inclusive and Supportive Culture
The organization promotes a diverse and inclusive work culture that values every individual’s contribution. Employees are encouraged to bring their full selves to work.
5. Competitive Compensation
The company offers competitive salary packages, performance-based bonuses, and a range of employee benefits including insurance and wellness programs.
Who Should Apply? Pharmacovigilance Japanese Drug Safety
This role is ideal for:
- Pharmacovigilance professionals with 1–4 years of experience
- Life science graduates with Japanese language proficiency
- Medical writers or safety associates with a strong interest in regulatory compliance
- Clinical research professionals transitioning into drug safety roles
- Candidates with experience in handling Japanese language ICSR documentation
Application Process Pharmacovigilance Japanese Drug Safety
Interested candidates can apply online through the Syneos Health career portal. Ensure that your resume is updated with relevant pharmacovigilance experience and clearly mentions Japanese language proficiency. Pharmacovigilance Japanese Drug Safety
Shortlisted candidates will undergo a screening process that includes an evaluation of technical knowledge, language skills, and case processing experience.
Similar Opportunities
If you are exploring pharmacovigilance careers, you might also be interested in:
- Pharmacovigilance Associate roles at Torrent Pharma
- Clinical Research Associate positions at IQVIA
- Drug Safety Officer openings at Biocon Biologics
- Regulatory Affairs roles at Thermo Fisher Scientific
Final Thoughts
Joining Syneos Health as a Safety & PV Specialist with Japanese language skills is not just a job — it’s an opportunity to contribute meaningfully to global drug safety while building a strong and fulfilling career. With its strong focus on employee development, patient safety, and innovation, Syneos Health is the right place for professionals who want to make a global impact. Pharmacovigilance Japanese Drug Safety
Stay ahead in your career by applying today.
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For More Information & Direct Application
Visit: Syneos Health Careers Page
Note: Link provided for information purposes. Please check official careers portal for the latest updates.
